U.S. patent application number 14/071929 was filed with the patent office on 2015-05-07 for fluid delivery devices and methods.
This patent application is currently assigned to PALO ALTO RESEARCH CENTER INCORPORATED. The applicant listed for this patent is PALO ALTO RESEARCH CENTER INCORPORATED. Invention is credited to Ramkumar Abhishek, Felicia Linn.
Application Number | 20150126968 14/071929 |
Document ID | / |
Family ID | 51904293 |
Filed Date | 2015-05-07 |
United States Patent
Application |
20150126968 |
Kind Code |
A1 |
Abhishek; Ramkumar ; et
al. |
May 7, 2015 |
FLUID DELIVERY DEVICES AND METHODS
Abstract
Devices and methods are provided for fluid delivery. The device
may include a housing having an outer surface which includes a
porous membrane, a fluid reservoir disposed in the interior region
of the main housing and formed at least in part by a wall
structure, a puncture mechanism operable to puncture the wall
structure and form a fluidic path between the fluid reservoir and
one or more channels in fluid communication with the porous
membrane, and a positive displacement mechanism operable, following
puncture of the wall structure, to drive a fluid out of the fluid
reservoir, through the one or more channels, and into the porous
membrane.
Inventors: |
Abhishek; Ramkumar;
(Mountain View, CA) ; Linn; Felicia; (San Jose,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PALO ALTO RESEARCH CENTER INCORPORATED |
Palo Alto |
CA |
US |
|
|
Assignee: |
PALO ALTO RESEARCH CENTER
INCORPORATED
Palo Alto
CA
|
Family ID: |
51904293 |
Appl. No.: |
14/071929 |
Filed: |
November 5, 2013 |
Current U.S.
Class: |
604/514 ;
604/131; 604/244; 604/500 |
Current CPC
Class: |
A61M 31/002
20130101 |
Class at
Publication: |
604/514 ;
604/244; 604/131; 604/500 |
International
Class: |
A61M 31/00 20060101
A61M031/00 |
Claims
1. A fluid delivery device, comprising: a main housing having an
interior region and having an outer surface which comprises a
porous membrane; a first fluid reservoir disposed in the interior
region of the main housing, the first fluid reservoir being formed
at least in part by a first wall structure and containing a first
fluid; a first puncture mechanism operable to puncture the first
wall structure and form a fluidic path between the first fluid
reservoir and one or more first channels, which are in fluid
communication with the porous membrane; and a first positive
displacement mechanism operable, following puncture of the first
wall structure, to drive the first fluid out of the first fluid
reservoir, through the one or more first channels, and into the
porous membrane, wherein the porous membrane is configured to
distribute the first fluid to an area adjacent to and outside of
the outer surface of the main housing.
2. The device of claim 1, wherein the first positive displacement
mechanism comprises an inflatable balloon.
3. The device of claim 1, wherein: the first fluid is contained
within a balloon disposed in the first fluid reservoir, and the
first positive displacement mechanism comprises a gas generating
mechanism configured to generate a gas to deflate the balloon and
displace the first fluid.
4. The device of claim 1, wherein the first puncture mechanism
comprises an annular channel in fluid communication with a needle
tip oriented to puncture the first wall structure.
5. The device of claim 1, further comprising a tension loaded
mechanism configured to allow a user to selectively cause the first
puncture mechanism to puncture the first wall structure.
6. The device of claim 1, wherein the outer surface and porous
membrane are cylindrical.
7. The device of claim 6, wherein the one or more first channels
extend from a first end of the porous membrane to an opposed second
end of the porous membrane.
8. The device of claim 1, further comprising: a second fluid
reservoir disposed in the interior region of the main housing, the
second fluid reservoir being formed at least in part by a second
wall structure and containing a second fluid; a second puncture
mechanism operable to puncture the second wall structure and form a
fluidic path between the second fluid reservoir and one or more
second channels, which are in fluid communication with the porous
membrane; and a second positive displacement mechanism operable,
following puncture of the second wall structure, to drive the
second fluid out of the second fluid reservoir, through the one or
more second channels, and into the porous membrane, wherein the
porous membrane is configured to distribute the second fluid to an
area adjacent to and outside of the outer surface of the main
housing.
9. The device of claim 8, wherein the one or more second channels
are distinct from the one or more first channels.
10. The device of claim 8, wherein: the first and second fluid
reservoirs each comprise an elongated annular tube with a closed
end wall, and the first and second wall structures respectively
comprise the closed end walls of the first and second fluid
reservoirs.
11. The device of claim 10, wherein: the first puncture mechanism
comprises a first annular channel in fluid communication with a
first needle tip configured to puncture the first wall structure,
the second puncture mechanism comprises a second annular channel in
fluid communication with a second needle tip configured to puncture
the second wall structure, and the first and second annular
channels are positioned together in a stacked and/or offset
arrangement within the interior region.
12. The device of claim 1, wherein a lumenal surface of each of the
one or more first channels adjacent to or within the porous
membrane is porous.
13. The device of claim 1, wherein the porous membrane comprises a
fluidic valve configured such that a critical threshold pressure
from about 0.1 psi to about 100 psi is required to distribute the
first fluid to the area adjacent to and outside of the outer
surface of the main housing.
14. The device of claim 1, wherein the porous membrane comprises an
aseptic barrier configured to substantially prohibit infiltration
into the device of bacteria having a size in excess of an average
pore size of the porous membrane.
15. The device of claim 1, wherein the porous membrane comprises a
membrane material selected from the group consisting of
polypropylene, polyethylene, polytetrafluoroethylene, and
combinations thereof.
16. The device of claim 1, wherein the porous membrane has an
average pore size from about 0.2 .mu.m to about 25 .mu.m.
17. The device of claim 1, wherein the first fluid comprises a
drug.
18. The device of claim 17, which is an implantable medical device
shaped and dimensioned for intravaginal deployment.
19. An implantable drug delivery device for controlled release of
two or more drugs to an intralumenal tissue surface, the device
comprising: a main housing configured for intralumenal deployment
in a patient, the main housing having an outer surface which
comprises a porous membrane; a first fluid reservoir within the
main housing and containing a first fluid which comprises a first
drug; a second fluid reservoir within the main housing and
containing a second fluid which comprises a second drug; a first
puncture mechanism operable to puncture the first fluid reservoir
and form a fluidic path between the first fluid reservoir and one
or more first channels, which are in fluid communication with the
porous membrane; a second puncture mechanism operable to puncture
the second fluid reservoir and form a fluidic path between the
second fluid reservoir and one or more second channels, which are
in fluid communication with the porous membrane; and at least one
positive displacement mechanism operable to (i) drive the first
fluid out of the first fluid reservoir, through the one or more
first channels, and into the porous membrane following puncture of
the first fluid reservoir, and (ii) drive the second fluid out of
the second fluid reservoir, through the one or more second
channels, and into the porous membrane following puncture of the
second fluid reservoir, wherein the porous membrane is operable to
distribute the first and second drugs to an intralumenal tissue
surface adjacent to the outer surface of the main housing.
20. A method of controlled delivery of a fluid to a target area,
comprising: positioning a fluid delivery device adjacent to the
target area, wherein the fluid delivery device comprises: a first
fluid reservoir defined by a first fluid reservoir housing, the
first fluid reservoir containing a first fluid; a first wall
structure forming at least a portion of the first fluid reservoir
housing; and a porous membrane forming an outer surface of the
fluid delivery device; puncturing the first wall structure with a
first puncture mechanism to provide a fluidic path between the
first fluid reservoir and one or more first channels in fluid
communication with the porous membrane; and driving the first fluid
out of the first fluid reservoir and into the one or more first
channels, such that the first fluid is delivered to the target area
from the device via the porous membrane.
21. The method of claim 20, wherein the first wall structure is
punctured prior to positioning the fluid delivery device adjacent
to the target area.
22. The method of claim 20, wherein driving the first fluid out of
the first fluid reservoir comprises generating a gas to inflate a
balloon within the first fluid reservoir and displace the first
fluid.
23. The method of claim 20, wherein: the device further comprises a
balloon containing the first fluid, the balloon being disposed in
the first fluid reservoir, and driving the first fluid out of the
first fluid reservoir comprises generating a gas to deflate the
balloon and displace the first fluid.
24. The method of claim 20, wherein the first fluid comprises a
drug and the target area is a mucosal tissue surface of a patient.
Description
FIELD
[0001] The present disclosure is generally in the field of fluid
delivery devices and methods, and more particularly to devices and
methods for the controlled delivery of one or more fluids,
including but not limited to implantable drug delivery devices.
BACKGROUND
[0002] Controlled fluid delivery is desirable in a variety of
applications, including drug delivery. However, it would be
desirable to provide improved devices and methods to independently
store and effectively deliver one or more fluids from a single
device to a target area. For example, it would be desirable to
provide a delivery system capable of separately storing two or more
fluids onboard a device, yet including shared means for controlled
fluid release from the device in a compact, space-efficient
device.
SUMMARY
[0003] In one aspect, a fluid delivery device is provided,
including: (i) a main housing having an interior region and having
an outer surface which includes a porous membrane, (ii) a first
fluid reservoir disposed in the interior region of the main
housing, the first fluid reservoir being formed at least in part by
a first wall structure and containing a first fluid, (iii) a first
puncture mechanism operable to puncture the first wall structure
and form a fluidic path between the first fluid reservoir and one
or more first channels, which are in fluid communication with the
porous membrane, and (iv) a first positive displacement mechanism
operable, following puncture of the first wall structure, to drive
the first fluid out of the first fluid reservoir, through the one
or more first channels, and into the porous membrane. The porous
membrane may be configured to distribute the first fluid to an area
adjacent to and outside of the outer surface of the main
housing.
[0004] In another aspect, an implantable drug delivery device for
controlled release of two or more drugs to an intralumenal tissue
surface is provided, the device including: (i) a main housing
configured for intralumenal deployment in a patient, the main
housing having an outer surface which includes a porous membrane,
(ii) a first fluid reservoir within the main housing and containing
a first fluid which includes a first drug, (iii) a second fluid
reservoir within the main housing and containing a second fluid
which includes a second drug, (iv) a first puncture mechanism
operable to puncture the first fluid reservoir and faun a fluidic
path between the first fluid reservoir and one or more first
channels, which are in fluid communication with the porous
membrane, (v) a second puncture mechanism operable to puncture the
second fluid reservoir and form a fluidic path between the second
fluid reservoir and one or more second channels, which are in fluid
communication with the porous membrane, and (vi) at least one
positive displacement mechanism operable to (a) drive the first
fluid out of the first fluid reservoir, through the one or more
first channels, and into the porous membrane following puncture of
the first fluid reservoir, and (b) drive the second fluid out of
the second fluid reservoir, through the one or more second
channels, and into the porous membrane following puncture of the
second fluid reservoir. The porous membrane may be operable to
distribute the first and second drugs to an intralumenal tissue
surface adjacent to the outer surface of the main housing.
[0005] In yet another aspect, a method of controlled delivery of a
fluid to a target area is provided, the method including: (i)
positioning a fluid delivery device adjacent to the target area,
wherein the fluid delivery device includes: (a) a first fluid
reservoir defined by a first fluid reservoir housing, the first
fluid reservoir containing a first fluid, (b) a first wall
structure forming at least a portion of the first fluid reservoir
housing, and (c) a porous membrane forming an outer surface of the
fluid delivery device, (ii) puncturing the first wall structure
with a first puncture mechanism to provide a fluidic path between
the first fluid reservoir and one or more first channels in fluid
communication with the porous membrane, and (iii) driving the first
fluid out of the first fluid reservoir and into the one or more
first channels, such that the first fluid is delivered to the
target area from the device via the porous membrane.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1A is a cross-sectional view of one embodiment of a
fluid delivery device having a single fluid reservoir, in a tissue
lumen, prior to puncturing the wall structure.
[0007] FIG. 1B is a cross-sectional view of the fluid delivery
device of FIG. 1A, after puncturing the wall structure and prior to
driving the fluid out of the fluid reservoir.
[0008] FIG. 1C is a cross-sectional view of the fluid delivery
device of FIG. 1A, while driving the fluid out of the fluid
reservoir and into the channels to deliver the fluid to the tissue
surface via the porous membrane.
[0009] FIG. 2A is a cross-sectional view of one embodiment of a
fluid delivery device having two fluid reservoirs, prior to
puncturing the wall structure of either reservoir.
[0010] FIG. 2B is a cross-sectional view of the fluid delivery
device of FIG. 2A, after puncturing the wall structure of the first
fluid reservoir and while driving the fluid out of that
reservoir.
[0011] FIG. 2C is a cross-sectional view of the fluid delivery
device of FIG. 2A, after puncturing the wall structure of the
second fluid reservoir and while driving the fluid out of that
reservoir.
[0012] FIG. 3A is an exploded perspective view of one embodiment of
a fluid delivery device having two fluid reservoirs and two
independent sets of channels in fluid communication with a porous
membrane.
[0013] FIG. 3B is a perspective view of the fluid delivery device
of FIG. 3A.
[0014] FIG. 4A is a perspective view of one embodiment of an
implantable drug delivery device having a porous membrane
sidewall.
[0015] FIG. 4B is an exploded perspective view of the drug delivery
device of FIG. 4A.
[0016] FIG. 5A is a cross-sectional view of one embodiment of a
fluid delivery device having a single fluid reservoir, in a tissue
lumen, prior to puncturing the wall structure.
[0017] FIG. 5B is a cross-sectional view of the fluid delivery
device of FIG. 5A, after puncturing the wall structure and prior to
driving the fluid out of the fluid reservoir.
[0018] FIG. 5C is a cross-sectional view of the fluid delivery
device of FIG. 5A, while driving the fluid out of the fluid
reservoir and into the channels to deliver the fluid to the tissue
surface via the porous membrane.
DETAILED DESCRIPTION
[0019] The fluid delivery devices and methods described herein
provide for the storage and controlled delivery of one or more
fluids from a single device. The devices are advantageously
configured to separately store and isolate the fluid(s), thereby
minimizing the risk of contamination, and to precisely dispense the
fluid(s) according to a desired release timing profile. For
example, these devices and methods may be used to deliver drugs to
a patient in vivo. The devices and methods disclosed herein can
significantly increase the accuracy and efficiency of delivering
multiple fluids, in a space-efficient manner, e.g., with minimal
duplication of the fluid delivering components, and without
unwanted mixing of the fluids to be released.
[0020] In certain embodiments, the fluid delivery devices include a
porous membrane to distribute the fluid(s) to the area adjacent the
device. However, the devices disclosed herein may also be
constructed without the porous membrane. For example, a device may
have a common gate or valve other than a porous membrane, which is
configured to distribute the fluid(s) to the area adjacent the
device.
[0021] In one aspect, a fluid delivery device is provided. As shown
in FIG. 1A, in one embodiment the device 100 includes a main
housing 112 having an interior region and having an outer surface
which includes a porous membrane 142. A first fluid reservoir 114
is disposed in the interior region of the main housing 112, and is
formed at least in part by a first wall structure 102. The first
fluid reservoir 114 contains a first fluid. The device 100 also
includes a first puncture mechanism 104 operable to puncture the
first wall structure 102 and form a fluidic path between the first
fluid reservoir 114 and one or more first channels 106, which are
in fluid communication with the porous membrane 142. The device 100
also includes a first positive displacement mechanism 122 operable,
following puncture of the first wall structure 102, to drive the
first fluid out of the first fluid reservoir 114, through the one
or more first channels 106, and into the porous membrane 142. The
porous membrane 142 is configured to distribute the first fluid to
an area adjacent to and outside of the outer surface of the main
housing 112.
[0022] In another aspect, a method of controlled fluid delivery to
a target area is provided. In certain embodiments, as shown in
FIGS. 1A-1C the method includes: (i) positioning a fluid delivery
device 100 adjacent to the target area, (ii) puncturing the first
wall structure 102 with a first puncture mechanism 104 to provide a
fluidic path between the first fluid reservoir 114 and one or more
first channels 106 in fluid communication with the porous membrane
142, and (iii) driving the first fluid out of the first fluid
reservoir 114 and into the one or more first channels 106, such
that the first fluid is delivered to the target area from the
device 100 via the porous membrane 142.
[0023] Various embodiments and features of the fluid delivery
devices and methods are described in greater detail
hereinafter.
Main Housing
[0024] The device includes a main housing having an interior region
and an outer surface. In certain embodiments, the outer surface of
the main housing includes a porous membrane. Generally, these
devices are configured to deliver one or more fluids to an area
adjacent to and outside of the outer surface of the main
housing.
[0025] The main housing of the device may be shaped and dimensioned
for a specific fluid delivery application. For example, as shown in
FIG. 1A, the device 100 may be an implantable medical device shaped
and dimensioned for intralumenal deployment into a human or animal
subject. The term "intralumenal," as used herein, refers to
placement within a body cavity, channel, tube, or the like, having
a mucosal wall. The term includes, but is not limited to, sites in
the reproductive tract, such as intravaginal, cervical, or
intrauterine, and the gastrointestinal tract, such as
intrarectal.
[0026] The housing configuration may be based upon the particular
lumenal site and human or animal anatomical considerations, for
deployment with minimal discomfort to the patient. In certain
embodiments, the device may be placed within the lumen by insertion
into the lumen via an exterior body orifice. Accordingly, in
certain embodiments, the housing is shaped and dimensioned to allow
insertion and placement, i.e., deployment, of the device within the
intended lumen via the exterior body orifice. For example, the
housing may be shaped and dimensioned for vaginal, cervical,
uterine, or rectal insertion and placement. As shown in FIGS. 4A
and 4B, the housing 712 may include an elongated, substantially
cylindrical outer surface and have wing-like portions, or arms, 750
extending therefrom. For example, this configuration may be
appropriate for vaginal device deployment in livestock, such as
cattle, sheep, etc.
[0027] The materials of construction, size, shape, surface
features, and other characteristics of the housing may be
configured such that the device can be deployed into the lumen,
retained securely in the lumen during operation of the device for
an extended period of time, and retrieved from the lumen following
operation of the device or when otherwise desired to be removed.
For example, the device may be removed between the delivery of
individual drug formulations, following the delivery of several
drug formulations, or following the completion of a course of
treatment of multiple drug formulations. The device may be deployed
until the drug formulation payload is depleted.
[0028] In certain embodiments, the housing is formed of a
biocompatible material. Moreover, the housing material may be
resistant to degradation in the mucosal environment of the lumen.
Examples of suitable housing materials include stainless steel,
titanium, and biocompatible polymers, such as polypropylene,
polyethylene, or other common polymers, such as nylon having a
biocompatible outer layer, e.g., silicone. The housing material may
include a coating to enhance biocompatibility and/or operation of
the device.
Reservoirs and Contents
[0029] At least one reservoir is disposed within the main housing
of the device and contains a fluid for delivery from the device.
The reservoir(s) may be shaped and dimensioned to fit within the
main housing and may be formed of materials that are suitable for
storing the fluid to be contained therein. Examples of suitable
reservoir materials include stainless steel, titanium, and
biocompatible polymers, such as polypropylene, polyethylene, or
other common polymers, such as nylon having a biocompatible outer
layer, e.g., silicone. In certain embodiments, the reservoir may be
formed at least in part by the inner surface of the main
housing.
[0030] As shown in FIG. 1A, the reservoir 114 is formed at least in
part by a first wall structure 102. The first wall structure may
include a puncturable material. Examples of suitable wall structure
materials include elastomeric polymers or other self-sealing
materials, such as silicone, PTFE, and synthetic and natural
rubber, and combinations thereof.
[0031] In certain embodiments, the device includes two or more
reservoirs, with each reservoir containing a fluid to be delivered
and being formed at least in part by a wall structure. In
particular embodiments, the fluids are drugs that are selected to
work in concert, and beneficially are delivered in parallel or
series, for example in a separated or overlapping schedule. In
certain embodiments, multiple reservoirs may contain a similar
fluid to be delivered in multiple administrations. For example, the
device may include multiple reservoirs containing the same drug to
be administered in discrete doses to a patient.
[0032] The reservoirs may be disposed within the housing such that
they are parallel to the housing and/or each other. The reservoirs
may each be defined by an inner surface of an elongated annular
tube. The reservoirs may also have a combined shape similar to that
of the housing and be configured such that the reservoirs occupy a
majority of the volume of the housing. In certain embodiments, the
reservoirs are elongated and have a circular cross-sectional shape.
In certain embodiments, the reservoirs together have a circular
cross-sectional shape, with each reservoir having a cross-sectional
shape that forms a portion of the circular shape. In one
embodiment, as shown in FIGS. 3A and 3B, each of two reservoirs
314, 316 has a semi-circular cross-sectional shape such that the
reservoirs together form a circular cross-sectional shape. Other
cross-sectional shapes are also envisioned. In certain
multi-reservoir embodiments, at least two of the reservoirs are
configured to have different volumes.
[0033] As shown in FIG. 2A, the device 200 includes a first
reservoir 214 containing a first fluid and a second reservoir 216
containing a second fluid. Both reservoirs 214, 216 are disposed in
the interior region of the main housing 212. The first reservoir
214 is formed in part by a first wall structure 202 and the second
reservoir 216 is formed in part by a second wall structure 203. In
certain embodiments, the first and second fluid reservoirs each
include an elongated annular tube with a closed end wall.
[0034] In certain embodiments, each reservoir has an actuation end
and an opposed release end. The actuation ends may be operably
connected to an actuation system. The release ends may include the
wall structure that is configured to be punctured by the puncture
mechanism. The actuation end of each reservoir includes a positive
displacement mechanism that is operable, following puncture of the
reservoir's wall structure, to drive the fluid out of the
reservoir. As shown in FIGS. 1A-1C, the device 100 includes a first
positive displacement mechanism 122 operable, following puncture of
the first wall structure 102, to drive the first fluid out of the
first fluid reservoir 114, through the one or more first channels
106, and into the porous membrane 142. In embodiments having
multiple reservoirs, each reservoir may be associated with a
separate positive displacement mechanism, as shown in FIGS. 2A-2C,
or two or more reservoirs may share a positive displacement
mechanism.
[0035] In certain embodiments, the positive displacement mechanism
includes an expandable membrane. For example, the expandable
membrane may include an inflatable balloon structure that expands
or inflates to drive the fluid out of the reservoir. The balloon
structure may be an elastomer, such as latex, nitrile or urethane
based, or it may be a collapsed balloon, such as a thin metallized
polymer sheet, e.g., polyester or polyethylene.
[0036] In other embodiments, as shown in FIGS. 5A-5C, the fluid is
contained within a balloon 522 disposed in the reservoir 514, and
the positive displacement mechanism includes a gas generating
mechanism configured to generate a gas to deflate the balloon and
displace the first fluid. As shown in FIG. 5A, in one embodiment
the device 500 includes a main housing 512 having an interior
region and having an outer surface which includes a porous membrane
542. A first fluid reservoir 514 is disposed in the interior region
of the main housing 512, and is formed at least in part by a first
wall structure 502. The first fluid reservoir 514 at least
partially contains balloon 522, which contains a first fluid. The
device 500 also includes a first puncture mechanism 504 operable to
puncture the first wall structure 502 and form a fluidic path
between the first fluid reservoir 514 and/or the balloon 522 and
one or more first channels 506, which are in fluid communication
with the porous membrane 542. The device 500 also includes positive
displacement mechanism operable, following puncture of the first
wall structure 502 (shown in FIG. 5B), to generate a gas in
communication with the balloon 522, to deflate the balloon 522 and
drive the first fluid out of the first fluid reservoir 514, through
the one or more first channels 506, and into the porous membrane
542, as shown in FIG. 5C. The porous membrane 542 is configured to
distribute the first fluid to an area adjacent to and outside of
the outer surface of the main housing 512.
[0037] Alternatively, the positive displacement mechanism may
include a plug or plunger structure configured to advance through
the reservoir and drive the fluid out of the reservoir. For
example, the plugs may sealingly engage with, and slide with
respect to, the inner walls of the reservoirs. The plugs may
function as pistons.
[0038] For example, the devices described herein may include one or
more of the reservoir and/or main housing features described in
U.S. patent application Ser. Nos. 13/629,124 and 13/629,159, the
disclosures of which are incorporated herein by reference in
pertinent part.
Release Structure
[0039] In embodiments, the device is configured to deliver the
fluid(s) to a target area adjacent the outer surface of the main
housing. To initiate the release of the fluid from a reservoir, the
wall structure of the reservoir is punctured by the puncture
mechanism and the positive displacement mechanism is actuated to
drive the fluid out of the reservoir. The puncture mechanism is
operable to puncture the wall structure and form a fluidic path
between the reservoir and one or more channels. In certain
embodiments, the channels are in fluid communication with a porous
membrane configured to distribute the fluid to an area adjacent to
and outside of the outer surface of the main housing. For example,
the one or more channels may extend along the length of the porous
membrane, such as in a helical or linear shape.
[0040] In certain embodiments, the puncture mechanism includes a
channel in fluid communication with a needle tip oriented to
puncture the wall structure of the reservoir. As shown in FIGS.
1A-1C, the first puncture mechanism 104 includes a channel in fluid
communication with a needle tip oriented to puncture the first wall
structure 102. In certain embodiments, as shown in FIGS. 3A and 3B,
the first puncture mechanism 304 includes an annular channel 305 in
fluid communication with a needle tip 307 oriented to puncture the
first wall structure 302.
[0041] As shown in FIGS. 2A-2C, the device 200 includes first and
second puncture mechanisms 204, 205 operable to puncture the first
and second wall structures 202, 203, respectively, and form a
fluidic path between the first and second fluid reservoirs 214,
216, and the first and second sets of channels 206, 207,
respectively, which are in fluid communication with the porous
membrane 242. First and second positive displacement mechanisms
222, 223 are operable, following puncture of the first and second
wall structures 202, 203, respectively, to drive the first and
second fluids out of the first and second fluid reservoirs 214,
216, through the first and second sets of channels 206, 207, and
into the porous membrane 242. The porous membrane 242 is configured
to distribute both the first and second fluids to the area adjacent
to and outside of the outer surface of the main housing 212. In one
embodiment, as shown in FIGS. 3A and 3B, the one or more first
channels 306 are distinct from the one or more second channels 308,
such that the fluidic paths for the first and second fluids may be
isolated from one another. For example, separate sets of channels
may decrease contamination.
[0042] In certain embodiments, the device includes a mechanism
configured to allow a user to selectively cause the first puncture
mechanism to puncture the first wall structure. As shown in FIGS.
1A-1C, the device 100 may include a push button 150 disposed on the
outer surface of main housing 112, such that it is accessible by a
user. For example, the device may include a first tension loaded
mechanism configured to advance the first reservoir towards the
puncture mechanism. In certain embodiments, the device includes a
single push button configured to cause all of the reservoirs in the
device to be punctured, in series or parallel. For example, the
device may be configured to puncture the reservoirs in series,
according to a predetermined timing schedule.
[0043] In certain embodiments, the puncture mechanism includes a
channel in fluid connection with the needle tip and configured to
form a fluidic path between the channels disposed in or adjacent to
the porous membrane. As shown in FIGS. 3A and 3B, the channel 305
of the first puncture mechanism 304 may be an annular channel. In
certain embodiments, the channel of the puncture mechanism is sized
and shaped to be adjacent the inner surface of the main housing. As
shown in FIGS. 3A and 3B, the channel 305 of the first puncture
mechanism 304 includes a radial aperture 310 in fluid communication
with the one or more first channels 306, which are in fluid
communication with the porous membrane 342. In certain embodiments,
each puncture mechanism includes one or more apertures or fluid
connections that provide the fluid communication with apertures or
fluid connections in the channels of the porous membrane.
[0044] As shown in FIGS. 3A and 3B, the first and second annular
channels 305, 312 may be positioned together in a stacked and/or
offset arrangement within the interior region of the main
housing.
[0045] For example, the needle tip of the puncture mechanism may be
constructed of drug-compatible, biocompatible plastics or metals,
such as stainless steel, and combinations thereof. The needle tip
may be stiff or soft. For example, the needle tip may be stiff to
assist in the puncturing process, or may be soft to assist in
plugging the mechanism to prevent leakage once engaged with the
reservoir. The channel of the puncture mechanism, as well as the
channels in communication with the porous membrane, may be
constructed of any drug-compatible, biocompatible tubing material,
such as silicone, PTFE, polypropylene, and polyethylene, and/or
metals, such as stainless steel.
[0046] Once the wall structure of the reservoir is breached by the
puncture mechanism, i.e., by advancing the reservoir toward the
puncture mechanism or advancing the puncture mechanism toward the
reservoir, the positive displacement mechanism is actuated to drive
the fluid out of the reservoir, through the fluidic path of the
puncture mechanism and into the associated channels, which are in
fluid communication with the porous membrane. For example, the
lumenal surface of each of the one or more channels adjacent to or
within the porous membrane may be porous, or include a plurality of
outlets for providing a fluidic path between the channels and the
porous membrane.
[0047] The porous membrane, or other common gate or valve
structures used in place of or in addition to the porous membrane,
may function to redirect or spread the fluid across a greater area
of the region adjacent the device. For example, in a drug delivery
device, the porous membrane sidewall may be configured to diffuse
and distribute the drug formulations released from the reservoirs
to the lumenal tissue. The porous membrane sidewall may be
configured to distribute the drug formulations driven from the
reservoirs to a tissue area adjacent the porous membrane sidewall
when the device is deployed intralumenally in a human or animal
subject.
[0048] The porous membrane may advantageously maximize the area
which is exposed to the dispensed fluids by diffusing the fluids
and distributing them across a large porous area on the outer
surface of the device. The surface area of the porous membrane, and
therefore the adjacent surface area to receive the fluid, may be
adjusted depending upon the targeted fluid and delivery site. The
porous membrane may also provide a reproducible wettable surface
condition that reduces variability in the administered fluid and
variability in the delivered fluid doses. Such features may be
beneficial over conventional technologies having individual ports
for each fluid to be dispensed. Such conventional devices may
suffer from random delivery patterns and a lack of control over
fluid and site exposure, resulting in highly variable dosing.
[0049] In one embodiment, the porous membrane operates as a fluidic
valve. For example, the porous membrane may have a pore structure
and chemistry such that a positive pressure is required to initiate
flow of the fluid(s) through the porous membrane. This thresholding
pressure may be tuned by controlling the average pore size of the
membrane's pore structure, as well as the contact angle of the
fluid on the surface of the membrane material. For example, the
porous membrane sidewall may be a fluidic valve configured such
that a critical threshold pressure from about 0.1 psi to about 100
psi is required to distribute the fluids to the area adjacent the
outer surface of the main housing.
[0050] The pore structure may be any microstructure representative
of an open pore structure. This may be a single layer of pores that
expend from one surface of the membrane through to the opposing
surface of the membrane. Alternatively, the pore structure may be a
randomly packed structure of interconnected pores or a highly
ordered, closed packed pores structure. For example, the porous
membrane may have an average pore size from about 0.2 .mu.m to
about 25 .mu.m.
[0051] In certain embodiments, the porous membrane acts as an
aseptic barrier. For example, the porous membrane may be configured
to substantially prohibit infiltration into the device of bacteria
having a size in excess of the effective average pore size of the
porous membrane.
[0052] The porous membrane may be constructed of a polycarbonate,
polypropylene, PFTE, or polyethylene membrane, or any combination
of laminates thereof. The membrane may also be constructed of two
or more dissimilar materials serving different functions outlined
above. For example, a PTFE and polyethylene laminate structure may
be used to achieve effective fluid solution spreading,
antimicrobial delivery, and valving. Alternatively, a composite
material may be constructed to achieve these desired functions for
fluids having differing wetting characteristics. This may be
achieved, for example, by using interwoven porous sheets
constructed of a predetermined ratio of hydrophobic to hydrophilic
materials.
[0053] In certain embodiments, upon generation of a positive
pressure via the positive displacement mechanism, the fluids are
driven from the reservoirs and through the porous membrane
sidewall. Once the pressure is reduced, the wetting condition will
become thermodynamically unfavorable and flow will stop.
[0054] In certain embodiments, the porous membrane provides a
surface that is in primary contact with body tissue and therefore
is composed of biocompatible materials. For example, the porous
membrane may include a polypropylene membrane. Other suitable
porous membrane materials include, but are not limited to,
polyethersulfone, polycarbonate, polyethylene terephthalate,
polyvinylidene fluoride, mixed cellulose ester, nylon 6,6,
polytetrafluoroethylene, and combinations thereof.
[0055] In certain embodiments, the porous membrane substantially
surrounds the main housing about the one or more reservoirs. For
example, the porous membrane may be cylindrical. In certain
embodiments, the porous membrane includes a first portion adjacent
the release ends (i.e., the ends near the puncture mechanisms) of
the reservoirs and a second portion adjacent the actuation ends of
the reservoirs such that the drug formulations are distributed from
both the first and second portions of the porous membrane. For
example, the one or more channels may extend from a first end
(i.e., at the release end) of the porous membrane to the opposed
second end (i.e., at the actuation end) of the porous membrane.
[0056] For example, the devices described herein may include one or
more of the release structure and/or multiple fluid delivery
features described in U.S. patent application Ser. Nos. 13/629,124
and 13/629,159, the disclosures of which are incorporated herein by
reference in pertinent part.
Actuation System
[0057] In certain embodiments, the device includes one or more
actuation systems which are configured to actuate the positive
displacement mechanism(s) and in turn drive the fluid(s) from the
reservoir(s). The one or more actuation systems may also be
configured to actuate puncture of the wall structures of the
reservoirs, i.e., by advancing the reservoir toward the puncture
mechanism or advancing the puncture mechanism toward the reservoir.
In one embodiment, a single actuation system may be configured to
actuate multiple positive displacement mechanisms, so as to drive
the first fluid from the first reservoir and drive the second fluid
from the second reservoir, in series or parallel. In another
embodiment, multiple actuation systems may be configured to actuate
multiple positive displacement mechanisms so as to drive multiple
fluids from multiple reservoirs.
[0058] The one or more actuation systems may be operably connected
to the actuation ends of each of the reservoirs. Generally, each
actuation system is configured to drive the fluid in the reservoir
via a positive displacement process. The term "positive
displacement," as used herein, refers to any process whereby the
drug formulations are dispensed from the drug delivery device under
force provided within each reservoir. Accordingly, the term does
not refer to the passive, chemical diffusion of the drug
formulations out of the reservoir, although passive diffusion may
contribute to release of the drug formulations from the porous
membrane.
[0059] As shown in FIG. 4B, the actuation system 738 may include a
power source 740, control circuitry 744, and an actuation mechanism
746. Embodiments having more than one actuation system may include
multiple actuation mechanisms and a shared power source and control
circuitry. Alternatively, embodiments having more than one
actuation system may include multiple individual actuations
systems, each having a power source, control circuitry, and
actuation mechanism.
[0060] The power source may be any source of mechanical, electrical
power or electromechanical power. The power source may include one
or more batteries or fuel cells. The control circuitry may be
configured to control the actuation system of the device, and
thereby control the timing of release of the fluids. For example,
the control circuitry may selectively transmit electrical and/or
mechanical power to the actuation mechanism, positively displacing
the fluid in the reservoirs. The control circuitry may be
configured to control the timing of delivery of the fluids by
applying the necessary electrical signals to the actuation
mechanism. The control circuitry may be programmable or it may be
pre-programmed to deliver the fluids in accordance with a
prescribed (predetermined) release schedule.
[0061] The actuation mechanism may include fluid-volume
displacement, mechanical displacement, osmotic swelling
displacement, electrostatically-induced compression, piezoelectric
actuation, thermally/magnetically induced phase transformation, or
combinations thereof, to drive the fluids from the reservoirs via
positive displacement. For example, the actuation mechanism may
include one or more of the actuation mechanisms described in U.S.
patent application Ser. Nos. 13/629,124 and 13/629,159, the
disclosures of which are incorporated herein by reference in
pertinent part.
[0062] In certain embodiments, the one or more actuation systems
are each configured to generate a displacement fluid in operable
communication with an inflatable balloon structure within each
reservoir. For example, the actuation system may include an
electrolytic cell having a cathode and an anode which is in contact
with water or an aqueous solution to generate a gas, such as
oxygen, thus providing a source of positive displacement to drive
the fluids out of the reservoirs.
[0063] In certain embodiments, the actuation system further
includes a wireless receiver for receiving wireless control signals
from a separate, detached transmitting device. For example, the
fluid delivery device may be deployed into the lumen of a patient
by the patient, physician, veterinarian, or the like, and
thereafter, the patient, physician, veterinarian, or the like, may
actuate the release of the fluids using the transmitting device to
transmit control signals to the deployed device. Furthermore, in
some embodiments, the receiver and transmitting device may both be
transceivers capable of transmitting and receiving control signals
and other communications from each other. For example, the receiver
and transmitting device may be configured to allow for wireless
programming and re-programming of the drug dosing regimen,
including the dosage, timing of drug release, etc. Accordingly, in
certain embodiments, the transceiver may transmit data relevant to
the operation of the device, such as data regarding the fluids
already administered, the release schedule, the amount of fluids
remaining in the reservoirs, and the remaining battery charge, as
well as data relevant to the environment of the deployment site,
such as data detected or measured by an integral sensor. In some
embodiments, the actuation system may also be wirelessly
powered.
[0064] In certain embodiments, the device may is configured for
wireless operation, e.g., following deployment in a human or animal
subject. In such cases, the device includes appropriate telemetry
components as known in the art. For example, actuation of the fluid
dispensing may be done from a remote controller, e.g., external to
a human or animal subject. Generally, the telemetry (i.e. the
transmitting and receiving) is accomplished using a first coil to
inductively couple electromagnetic energy to a
matching/corresponding second coil. The means of doing this are
well established, with various modulation schemes such as amplitude
or frequency modulation used to transmit the data on a carrier
frequency. The choice of the carrier frequency and modulation
scheme will depend on the location of the device and the bandwidth
required, among other factors. Other data telemetry systems known
in the art also may be used. In another case, the device is
configured to be remotely powered, or charged. For example, the
device may include a transducer for receiving energy wirelessly
transmitted to the device, circuitry for directing or converting
the received power into a form that can be used or stored, and if
stored, a storage device, such as a rechargeable battery or
capacitor. In still another case, the device is both wirelessly
powered and wirelessly controlled.
Drug Formulations
[0065] In certain embodiments, the fluid delivery device is an
implantable drug delivery device for the controlled release of one
or more drugs to an intralumenal tissue surface of a patient. In
such embodiments, one or more drug formulations are contained
within the device reservoirs for delivery to the mucosal tissue. In
one embodiment, two or more drug formulations are disposed within
two reservoirs for release to a subject.
[0066] Various drug formulations may be administered from the drug
delivery device. The drug formulations within each reservoir may
each include the same drug, may each include different drugs, or
may be some combination of more than one similar drug and more than
one different drug. For example, the first drug formulation may
include a different drug than the second drug formulation. For
example, the first and third drug formulations may both include the
same drug, and second drug formulations may include a different
drug than the first and third drug formulations. In certain
embodiments, the device may be used to deliver a battery of drug
formulations for a combination therapy, prophylaxis, or for another
specific treatment, such as may be useful in animal husbandry.
[0067] In one embodiment, the device is used to deliver a fixed
time artificial insemination treatment to a human or animal
subject. In certain embodiments, the first drug formulation
includes a gonadotropin-releasing hormone, the second drug
formulation includes a prostaglandin, and the third drug
formulation includes a gonadotropin-releasing hormone. In one
embodiment, the device also includes a fourth drug formulation
which includes a progestin. Variations of the drugs and sequences
are envisioned.
[0068] In embodiments, the drug formulations include one or more
proteins or peptides. For example, in some embodiments, the drug
delivery device may be used to administer hormones or steroids.
including, but not limited to, follicle stimulating hormone,
parathyroid hormone, luteinizing hormone, gonadotropin-releasing
hormone (GnRH), estradiol, progesterone, melatonin, serotonin,
thyroxine, triiodothyronine, epinephrine, norepinephrine, dopamine,
antimullerian hormone, adiponectin, adrenocorticotropic hormone,
angiotensinogen, angiotensin, antidiuretic hormone,
atrial-natriuretic peptide, calcitonin, cholecystokinin,
corticotropin-releasing hormone, erythropoietin, gastrin, ghrelin,
glucagon, growth hormone-releasing hormone, human chorionic
gonadotropin, human placental lactogen, growth hormone, inhibin,
insulin, insulin-like growth factor, leptin, melanocyte stimulating
hormone, orexin, oxytocin, prolactin, relaxin, secretin,
somatostatin, thrombopoietin, thyroid-stimulating hormone,
thyrotropin-releasing hormone, cortisol, aldosterone, testosterone,
dehydroepiandrosterone, androstenedione, dihydrotestosterone,
estrone, estriol, calcitriol, calcidiol, prostaglandins,
leukotrienes, prostacyclin, thromboxane, prolactin releasing
hormone, lipotropin, brain natriuretic peptide, neuropeptide Y,
histamine, endothelin, enkephalin, renin, and pancreatic
polypeptide.
[0069] In some embodiments, the drug delivery device may be used to
administer cytokine signaling molecules or immunomodulating agents
that are used in cellular communication. These molecules commonly
comprise proteins, peptides, or glycoproteins. Cytokine signaling
molecules include, for example, the four a-helix bundle family
which include the IL-2 subfamily (e.g., erythropoietin (EPO) and
thrombopoietin (THPO)), the interferon (IFN) subfamily and the
IL-10 subfamily. Cytokine signaling molecules also include the
IL-1, IL-18, and IL-17 families.
[0070] In some embodiments, the drug delivery device may be used to
administer drug formulations for pain management, including, but
not limited to, corticosteroids, opioids, antidepressants,
anticonvulsants (antiseizure medications), non-steroidal
anti-inflammatory drugs, COX2 inhibitors (e.g., rofecoxib and
celecoxib), ticyclic antidepressants (e.g., amitriptyline),
carbamazepine, gabapentin and pregabalin, codeine, oxycodone,
hydrocodone, diamorphine, and pethidine.
[0071] In some embodiments, the drug delivery device may be used to
administer cardiovascular drug formulations. Examples include
B-type natriuretic peptide (BNP), atrial natriuretic peptide (ANP),
atrial natriuretic factor (ANF), atrial natriuretic hormone (ANH),
and atriopeptin. Cardiovascular drug formulations that may be
administered by the device also include, for example,
antiarrhythmic agents, such as Type I (sodium channel blockers),
including quinidine, lidocaine, phenytoin, propafenone; Type H
(beta blockers), including metoprolol; Type III (potassium channel
blockers), including amiodarone, dofetilide, sotalol; Type IV (slow
calcium channel blockers), including diltiazem, verapamil; Type V
(cardiac glycosides), including adenosine and digoxin. Other
cardiacvascular drug formulations that may be administered by the
device include ACE inhibitors, such as, for example, captopril,
enalapril, perindopril, ramipril; angiotensin II receptor
antagonists, such as, for example, candesartan, eprosartan,
irbesartan, losartan, telmisartan, valsartan; beta blocker; and
calcium channel blocker.
[0072] The drug formulations may be formulated with one or more
pharmaceutically acceptable excipients as needed to facilitate the
drug's storage in and release from the device. In one embodiment,
the drug may be in a liquid solution or suspension. The drug may be
in the form of microparticles or nanoparticles. The solvent or
carrier may be aqueous or organic. For example, the devices and
methods described herein may further include a reconstitution
mechanism as described in U.S. patent application Ser. No.
13/629,184, the disclosure of which is incorporated herein by
reference in pertinent part.
[0073] In some embodiments, the drug formulations may include
components that are degradable by the enzymes present in the fluid
secreted by the mucosal tissue. For example, certain amino acids
present in drug formulations may be degraded by the enzymes present
in fluid secreted by the mucosal tissue. Accordingly, the devices
and methods described herein may further include one or more of the
permeation enhancement mechanisms described in U.S. Patent
Application Publications No. 2011/0087195, No. 2011/0087192, and
No. 2011/0087155, the disclosures of which are incorporated herein
by reference in pertinent part.
Methods
[0074] Methods are provided for controlled delivery of fluid(s) to
a target area. The devices may include any combination of the
device feature described herein. In certain embodiments, as shown
in FIGS. 1A-1C the method includes: (i) positioning a fluid
delivery device 100 adjacent to the target area, (ii) puncturing
the first wall structure 102 with a first puncture mechanism 104 to
provide a fluidic path between the first fluid reservoir 114 and
one or more first channels 106 in fluid communication with the
porous membrane 142, and (iii) driving the first fluid out of the
first fluid reservoir 114 and into the one or more first channels
106, such that the first fluid is delivered to the target area from
the device 100 via the porous membrane 142.
[0075] In certain embodiments, the methods include deploying a drug
delivery device into the mucosal lumen of a human or animal
patient. For example, the subject may be a mammalian animal (e.g.,
cow, sheep, horse, pig, or dog). The methods include various
medical and veterinary therapies, as well as animal husbandry
applications. The lumen may be, for example, a vagina, cervix,
uterus, bladder, or rectum. The device may be adapted to contact
essentially any mucosal tissue surface. The device may be placed in
the lumen by inserting the device through an exterior orifice of
the patient into the lumen. In some embodiments, the device may be
in a form that may be orally administered for delivery of a drug
via the mucosal tissue of the gastrointestinal tract.
[0076] In certain embodiments, the first wall structure is
punctured prior to positioning the fluid delivery device adjacent
to the target area. For example, as shown in FIGS. 1A-1C, a user
may press the button 150, to actuate puncturing of the wall
structure 102, prior to positioning the device within a bodily
lumen 160. In other embodiments, the puncturing of one or more wall
structures may be actuated wirelessly after the device has been
positioned.
[0077] In certain embodiments, driving the fluid out of the fluid
reservoir includes generating a gas to inflate the balloon within
the fluid reservoir and displace the fluid. In other embodiments,
the device further includes a balloon containing the first fluid
disposed in the first fluid reservoir, and driving the first fluid
out of the first fluid reservoir includes generating a gas to
deflate the balloon and displace the first fluid. For example, in
devices having multiple reservoirs, the fluid in the first
reservoir may be completely or partially released from the first
reservoir before the release of the fluid from the second
reservoir.
[0078] As illustrated in FIG. 1, the fluid delivery device 100 may
be placed in a lumen 160. The device may be held in place by
frictional engagement between the mucosal tissue and the main
housing. As shown in FIGS. 4A-4B, arms 750 may be provided to
facilitate retention of the device within the mucosal lumen. The
fluids may then be driven out of the reservoirs and into the porous
membrane 742 from which the drug formulations are then released to
the surrounding area. The actuation of the actuation system may be
controlled by the control circuitry 744. The device may thereafter
be removed from the lumen. For example, the devices described
herein may include one or more of the retention features described
in U.S. patent application Ser. No. 13/742,203, the disclosure of
which is incorporated herein by reference in pertinent part.
[0079] The fluid delivery devices may include any of the device
features described herein. For example, the device may include a
microcontroller configured to control the actuation system, and
thereby control the timing of the release of the fluids.
Applications/Uses
[0080] The fluid delivery devices and methods may be used for any
applications in which controlled fluid delivery to a target area is
needed. For example, the fluid delivery devices and methods may be
used for various medical and therapeutic applications in human and
animal subjects, as well as in animal husbandry. In certain
embodiments, the fluids are drug formulations.
[0081] In one embodiment, an implantable drug delivery device for
the controlled release of two or more drugs to an intralumenal
tissue surface is provided. The device includes a main housing
configured for intralumenal deployment in a patient and having an
outer surface which includes a porous membrane. First and second
fluid reservoirs are contained within the main housing, and contain
a first drug and a second drug, respectively. The first and second
drugs may be the same drug formulation or different drug
formulations. A first puncture mechanism is operable to puncture
the first fluid reservoir and form a fluidic path between the first
fluid reservoir and one or more first channels, which are in fluid
communication with the porous membrane. A second puncture mechanism
is operable to puncture the second fluid reservoir and form a
fluidic path between the second fluid reservoir and one or more
second channels, which are also in fluid communication with the
porous membrane. At least one positive displacement mechanism is
operable to (i) drive the first fluid out of the first fluid
reservoir, through the one or more first channels, and into the
porous membrane following puncture of the first fluid reservoir,
and (ii) drive the second fluid out of the second fluid reservoir,
through the one or more second channels, and into the porous
membrane following puncture of the second fluid reservoir. The
porous membrane is operable to distribute the first and second
drugs to an intralumenal tissue surface adjacent to the outer
surface of the main housing.
[0082] In some embodiments, the drug delivery device may be used to
treat infertility or provide a fixed time artificial insemination
(FTAI) treatment in a female subject. For example, the drug
delivery device may be placed in the vagina (or uterus, or other
part of the birth canal) of a female subject. The drug delivery
device may then deliver follicle stimulating hormone to induce
ovulation in the female subject. In some embodiments, the drug
delivery device may be configured to deliver a plurality of
hormones, including follicle stimulating hormone, luteinizing
hormone, gonadotropin-releasing hormone separately, or in
combination, in appropriate sequences, at appropriate times, and in
pharmacologically appropriate amounts. The device may also dispense
estradiol to regulate natural hormone production in the female
subject. The appropriate dosing schedule and amounts may be
determined by one in the field of reproductive pharmacology.
[0083] Compared to traditional FTAI treatments, the methods
described herein may require only device implantation and removal
at the time of artificial insemination, and result in a reduction
in time spent driving, herding and chuting cattle. The methods also
result in improved ovulation quality and quantity due to the
reduction in handling, stress, and systemic cortisol levels of the
subjects. The methods also reduce the number of medical supplies
needed, as a single device delivery the series of FTAI drugs.
[0084] In another embodiment, the drug delivery device may be used
to treat insulin dependent diabetes (Type I diabetes) in a subject.
The drug delivery device may be placed within a lumen of the
subject. The drug delivery device may then deliver insulin (Humulin
R, Novolin R), insulin isophane (Humulin N, Novolin N), insulin
lispro (Humalog), insulin aspart (NovoLog), insulin glargine
(Lantus) or insulin detemir (Levemir) to the patient at a selected
time or times.
[0085] In another embodiment, the drug delivery device may be used
to treat diabetes mellitus (Type II diabetes) in a subject. The
drug delivery device may be placed within a lumen of the subject.
The drug delivery device may then deliver exenatide to the patient
at a selected time or times.
[0086] In another embodiment, the drug delivery device may be used
to treat breast or ovarian cancer in a subject. The drug delivery
device may be placed within a lumen of the subject, such as the
vagina for a female subject. The drug delivery device may then
deliver abraxane (or other drug effective in the treatment or
management of cancer) to the patient at a selected time or
times.
[0087] In another embodiment, the drug delivery device may be used
to treat HIV/AIDS in a subject. The drug delivery device may be
placed within a lumen of the subject. The drug delivery device may
then deliver Abacavir (ABC) or Cidofovir (or other drug effective
in the treatment or management of HIV/AIDS) to the patient at a
selected time or times. The device also may be used to treat other
sexually transmitted diseases.
[0088] In another embodiment, the drug delivery device may be used
to treat genital herpes in a subject. The drug delivery device may
be placed within a lumen of the subject, such as within the vagina
of a female subject. The drug delivery device may then deliver
acyclovir, famciclovir, or valacyclovir (or other drug effective in
the treatment or management of genital herpes) to the patient at a
selected time or times.
[0089] In another embodiment, the drug delivery device may be used
to treat diabetes insipidus in a subject. The drug delivery device
may be placed within a lumen of the subject. The drug delivery
device may then deliver desmopressin (or other drug effective in
the treatment or management of diabetes insipidus) to the patient
at a selected time or times.
[0090] In another embodiment, the drug delivery device may be used
to treat osteoporosis in a subject. The drug delivery device may be
placed within a lumen of the subject, such as within the vagina of
a female subject. The drug delivery device may then deliver
ibandronate, calcitonin, or parathyroid hormone (or other drug
effective in the treatment or management of osteoporosis) to the
patient at a selected time or times.
[0091] Overall, the devices and methods described herein provide a
means to deliver multiple fluids through a common distribution
means (e.g., gate, valve, porous membrane). The devices take
advantage of the common porous membrane, while providing the
ability to engage the reservoir-membrane fluidic connection just
before use. Thus, this engaging mechanism allows the reservoirs to
remain unbreached during shipping and on the shelf, thus
maintaining the chemical and biological integrity of the fluids
contained therein, such as drugs. Moreover, the device structure
allows each fluid to be delivered via individual and isolated
channels, thereby enabling independent access to the common
membrane for each fluid dispensed and reducing the potential for
contamination.
[0092] It will be appreciated that various of the above-disclosed
and other features and functions, or alternatives thereof, may be
desirably combined into many other different devices, methods, or
applications. Various presently unforeseen or unanticipated
alternatives, modifications, variations, or improvements therein
may be subsequently made by those skilled in the art which are also
intended to be encompassed by the following claims.
* * * * *